Overview
PREVENT is a prospective, multicenter, interventional study evaluating the performance of the OverC multi-cancer detection blood test in asymptomatic individuals with cancer risk.
Description
Participants will receive the OverC multi-cancer detection blood test along with standard-of-care screening, whose results will be returned to health care providers and participants. The diagnostic procedures will be guided firstly by the OverC multi-cancer detection blood test and then by the standard-of-care screening. The number, cancer types, and cancer clinical stage of cancer patients diagnosed via the OverC multi-cancer detection blood test will be recorded.
The study will enroll approximately 12,500 participants as defined by eligibility criteria with an anticipated enrollment period of approximately 9 months at up to 30 clinical sites within China. Participants will be actively followed for approximately 5 years from the date of their enrollment.
Eligibility
Inclusion Criteria:
- Participants must be able to provide a written informed consent form
- Participants must not have received any colonoscopy, abdominal MRI/CT, low-dose CT, or chest CT within 5 years before signing the informed consent form
- Participants must be able to provide blood samples for study tests
- Participants must be between 40 and 75 years old
Exclusion Criteria:
- Individuals who have an acute infection or inflammation within 14 days prior to recruitment
- Individuals with cancer-associated clinical symptoms or suspected of cancer
- Recipient of organ transplant or prior non-autologous (allogeneic) bone marrow or stem cell transplant
- Recipient of blood transfusion within 7 days prior to recruitment
- Individuals who have pure ground-glass opacity
- Unable to provide blood samples for the multi-cancer early detection blood test
- Individuals who are unable to tolerate standard-of-care cancer screening tests or have contraindications of standard-of-care cancer screening tests
- Individuals who have taken medication with anti-tumor effects within 30 days prior to recruitment
- Individuals who have received or are undergoing curative cancer treatment within three years prior to recruitment
- Individuals with hemorrhagic diseases
- Individuals with autoimmune diseases
- Individuals who are pregnant or lactating
- Individuals who have severe comorbidities that are not suitable for participating in the trial judged by researchers